Early Post Transplant Cardiac Allograft Vasculopathy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- CAV on invasive coronary studies
研究概览
简要总结
Heart transplantation is an effective life-saving treatment for patients with end-stage heart disease. After a transplant, the new heart may develop narrowing in the arteries, causing heart failure, heart attacks and abnormal heart rhythms. This condition is known as cardiac allograft vasculopathy (CAV). The disease is very common, affecting almost a third of heart transplant patients by 5 years after transplant. CAV is a serious problem that causes the new heart to fail and is one of the main causes of death after transplant. Early detection of CAV is important as treatment options are poor once the disease is established. Currently, available techniques to evaluate CAV are limited by poor ability to detect disease early. The current tests usually focus on the large heart arteries and do not examine the smaller arteries that are also affected.
详细描述
The objective of this study is to determine whether early abnormalities of the heart arteries after heart transplantation can predict the development of CAV. We will use a combination of sophisticated imaging tools to examine in detail the early changes that occur in the arteries of a new heart. Heart transplant patients from the University of Ottawa Heart Institute and Toronto General Hospital will undergo a series of tests at 3 and 12 months after transplant. Statistical analyses will determine whether results from the above tests at 3 months predict the development of early CAV at 12 months after a heart transplant.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart transplant <3 months.
- •Age ≥18 years.
- •Able and willing to provide informed consent.
排除标准
- •Contraindications to dipyridamole.
- •Contraindications to aminophylline.
- •Contraindications to nitroglycerin.
- •Contraindications to iodinated contrast.
- •Acute allograft rejection ≤1 month.
- •Uncontrolled heart failure or myocardial infarction ≤7 days.
- •Estimated glomerular filtration rate ≤30 mL/min.
- •Combined solid organ transplantation.
结局指标
主要结局
CAV on invasive coronary studies
时间窗: 3 months and 1-year post-transplant.
Changes in coronary intima on IVUS and OCT and invasive coronary flow
次要结局
- PET(3 months post-transplant)
- EMBx(3 months post-transplant)
- Biomarkers(3 months post-transplant)